FDA Approval for ONPATTRO issued to ALNYLAM PHARMS INC
$ALNY
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 210922
Company: ALNYLAM PHARMS INC
Company: ALNYLAM PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ONPATTRO | PATISIRAN SODIUM | EQ 10MG BASE/5ML (EQ 2MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/10/2018 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210922s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210922Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210922Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/04/2022 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/06/2021 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210922s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210922Orig1s009ltr.pdf | |
| 04/17/2020 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210922s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210922Orig1s007ltr.pdf | |
| 09/16/2019 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210922s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210922Orig1s004ltr.pdf | |
| 05/06/2019 | SUPPL-1 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210922Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210922s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/06/2021 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210922s009lbl.pdf | |
| 04/17/2020 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210922s007lbl.pdf | |
| 09/16/2019 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210922s004lbl.pdf | |
| 05/06/2019 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210922Orig1s001lbl.pdf | |
| 08/10/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210922s000lbl.pdf |